UCARE Polymer JR-30M

Transcription

1 Regulatory Data Sheet UCARE Polymer JR-30M RDS_ _UCARE Polymer JR-30M INCI Name The International Nomenclature of Cosmetic Ingredients (INCI) Name of this product is Polyquaternium-10. Global Chemical Inventory Compliance Country Inventory Statement Australia Canada AICS DSL Australian AICS: All components are on the AICS Inventory or are not required to be listed. Canadian DSL: All components are on the DSL Inventory or are not required to be listed. China IECS Chinese IECSC: All components are on the IECSC Inventory. Europe Japan EINECS MITI European EINECS: The polymer in this product meets the definition of a polymer and is exempt from listing on the EINECS inventory. All other components of this product comply. Japanese MITI: This product contains one or more component(s), which is not listed on the MITI Inventory. However these component(s) are exempt from the inventory if the product is used only in cosmetic applications. Korea KECI Korean KECI: All components are on the KECI Inventory or are not required to be listed. New New Zealand NZIoC: All components are on the NZIoC Inventory or are not NZIoC Zealand required to be listed. Philippines PICCS Philippines PICCS: All components are on the PICCS Inventory or are not required to be listed. United TSCA U.S. TSCA: All components are on the TSCA Inventory. States REACH For information on the REACH status of this product, please request a REACH Product Information Sheet (PIS) from The Dow Customer Information Group at Page 1 of 7 Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Effective Date: 8/8/2014

2 China FDA Status The INCI name of the key ingredient in this product is listed in the China Existing Cosmetic Ingredient List as an approved cosmetic ingredient. EU Cosmetic Status This product complies with Council Directive 76/768/EEC and its 7th Amendment as well as Regulation (EC) No 1223/2009 on cosmetic products. Product Composition For product composition, please request a US MSDS for this product from The Dow Customer Information Group at Preservative No preservative is intentionally added to this product. Parabens and formaldehyde-releasers are not added to this product. We do not expect these substances to be present in the raw materials used to produce this product. Animal Derived Components With regards to Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE), we do not intentionally add, nor would we expect any component of this product to be derived from bovine, ovine, caprine, porcine or related ingredients of animal origin. This product is derived from materials of synthetic, petrochemical and/or mineral origins. The manufacturing equipment for the product is not used for the manufacture of products of animal origin or products containing ingredients of animal origin. This product is not stored with products of animal origin or products containing ingredients of animal origin. Kosher With regards to Kosher status, this product is free of wheat, oat, barley or rye derivatives. Although this product has not been officially certified by a Rabbinical council, we believe this product is judged to be pareve within the framework of the Jewish definition. We are disclosing above information, to the best of knowledge based upon data from our raw material suppliers and our manufacturing process. Page 2 of 7 Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Effective Date: 8/8/2014

3 Halal With regards to Halal status, this product is free of wheat, oat, barley or rye derivatives. Although this product has not been officially certified by a Islamic council, we believe this product is judged to be permitted under Muslim standards. We are disclosing above information, to the best of knowledge based upon data from our raw material suppliers and our manufacturing process. Food Allergens This product does not contain any of the eight major food allergens (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and/or soybeans) or proteins as listed in the FALCPA of 2004 and in FDA Guidance Sec and does not contact these food allergen during the manufacturing process. This product does not contain any of the 26 allergen ingredients as defined in the Cosmetics Products Regulation (EC) 1223/2009. Based on our knowledge of the manufacturing process and the raw materials used to produce this product, the following materials are not expected to be present in this product. Peanuts or peanut products (butter, oil, flour) Tree nuts (almonds, pecans, walnuts, Brazil nuts, cashew, chestnuts, etc.) Plant derivates, including nuts and seeds Eggs or egg products (whites, yolks, meringue, mayonnaise, etc.) Fish (cod, flounder, salmon, trout, tuna, etc.) Shellfish (crustaceans and mollusks) Celery (root, leaves, stalk, not seeds) Dairy or dairy derivatives Cereals containing gluten Wheat or wheat products Corn or corn derivatives Soybean or soy products (soy derived vegetable protein, tofu, etc.) Sulfites Artificial or natural colors including FD&C Yellow #5 and #6 Preservatives and antioxidants Umbelliferae (carrot or parsley family) Flavors/enhancers Nitrites/nitrates Materials from Genetically Modified Organisms One of the raw materials used in the manufacture of this product may have been derived from genetically modified organisms (GMO). Page 3 of 7 Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Effective Date: 8/8/2014

4 California Proposition 65 (Safe Drinking Water and Toxic Enforcement Act of 1986) To the best of our knowledge, this product does not contain any contaminants or by products known to the State of California to cause cancer or reproductive toxicity as listed under the Proposition 65 State Drinking Water and Toxic Enforcement Act. Residual Solvents None of the Class 1 or Class 2 Residual Solvents specified in USP General Chapter <467> effective on 1 JUL 2008 are used in the manufacture of this product. A Class 3 solvent, isopropanol, is used in production of this product. CMR UCARE Polymers are manufactured using glyoxal (CAS# ) as a surface treatment that enables such polymers to be readily soluble in cold aqueous solutions or aqueous fatty emulsions. Glyoxal is classified in the European Union, following the Global Harmonisation Scheme (GHS) of classification, as a category 2 mutagen. The maximum level of glyoxal detected in UCARE Polymers by the CEFIC method is less than 20 ppm. Glyoxal per se has been approved as safe for use in cosmetic products at levels up to 100 ppm by the European Union Scientific Committee on Consumer Safety (SCCP/0881/05 Decision dated June 21st 2005). Nanomaterials This product does not meet the definition of a nanomaterial as listed in Article 2(k) of the EU Cosmetic Regulation. This product would not trigger the notification requirements of Article 16 or the need for any further safety assessment that is required for a cosmetic product due to the presence of nanomaterials. Endocrine Disruptors To the best of our knowledge, this product does not contain any potential endocrine disruptors. EU Directive 2002/95/EC (RoHS) as amended by 2008/385/EC EU Directive 2011/65/EU (the Recast for EU Directive 2002/95/EC) on the restriction of the use of certain hazardous substances in electrical and electronic equipment requires that electrical and electronic equipment placed on the EU market does not contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyl, polybrominated biphenyl ether. We hereby confirm that in the manufacture of this product, we do not intentionally use lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyl or polybrominated biphenyl ether. Based upon data from our raw material suppliers and knowledge of the manufacturing process, we have no reason to believe that these substances are present. Page 4 of 7 Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Effective Date: 8/8/2014

5 Heavy Metals, EU 94/62/EC and Coalition of Northeastern Governors (CONEG) This product has not been analyzed for heavy metal content. To the best of knowledge, based upon data from our raw material suppliers and our manufacturing process, we do not expect to find heavy metals in this product. Impurities Glyoxal (CAS ) is used as a surface treatment that enables such polymers to be readily soluble in cold aqueous solutions or aqueous fatty emulsions. Glyoxal has been approved as safe for use in cosmetic products at levels up to 100 ppm (SCCP/0881/05 Decision dated June 21st 2005). Currently the CEFIC method ( is the only method of glyoxal quantitation that is generally accepted by both the European Union and the major manufacturers of cellulosic Polymers. When UCARE Polymers were analyzed using the CEFIC methodology, the maximum level of glyoxal detected was <20 ppm. In fact, in most instances, the concentration of glyoxal was below the detection limit of 5-8 ppm. Assuming a maximum of 20 ppm glyoxal in the UCARE Polymer, and assuming that these polymers are typically used at <0.5% in cosmetic formulations, use of UCARE Polymers would contribute a maximum of 0.1 ppm glyoxal, as measured by the CEFIC methodology, to a finished cosmetic formulation. Clean Air Act To the best of our knowledge, with regards to the Clean Air Act, Section 112(b), this product does not contain any Hazardous Air Pollutants (HAPs) at or above 0.1%. To the best of our knowledge, this product does not contain any components that are listed on the Clean Air Act Sec. 602 Class I and II Ozone Depleting Substances List (40 CFR 82). Clean Water Act To the best of our knowledge, this product does not contain any components that are listed on the Clean Water Act Toxic Pollutant List in 40 CFR Substances of Very High Concern (SVHC) This product does not contain any of the substances on the Substances of Very High Concern (SVHC) list at 0.1% as defined by the European Chemical Agency on 3 December We also encourage you to visit our REACH website where you will be able to find and download the most recent REACH related documents on our products. Page 5 of 7 Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Effective Date: 8/8/2014

6 Certificate of Analysis For product specifications, please request a Sales Spec document for this product from The Dow Customer Information Group at Micro Specifications Microbiological parameters are not part of the sales specifications for UCARE Polymers. During the manufacturing process, the material is washed in alcohol and dried at elevated temperatures. Every batch of UCARE Polymers was tested for over 10 years by an independent lab using the method known as USP 61. During that time, all results were negative for growth of any type of microorganism. In addition, there have been no documented instances of microbiological quality issues with UCARE Polymers to date. Even though UCARE Polymers are not routinely tested for microbial content, it is reasonable to expect a bioburden of less than 100 cfu/g of Polymer with the absence of pathogens in intact, factory sealed containers as supplied by The Dow Chemical Company. Shelf Life For information on shelf life or country of origin, please contact the The Dow Customer Information Group at Page 6 of 7 Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Effective Date: 8/8/2014

7 Product Stewardship The Dow Chemical Company and its subsidiaries ( Dow ) has a fundamental concern for all who make, distribute, and use its products, and for the environment in which we live. This concern is the basis for our Product Stewardship philosophy by which we assess the safety, health, and environmental information on our products and then take the appropriate steps to protect employee and public health and our environment. The success of our product stewardship program rests with each and every individual involved with Dow products from the initial concept and research, to manufacture, use, sale, disposal and recycle of each product. Customer Notice Dow strongly encourages its customers to review both their manufacturing processes and their applications of Dow products from the standpoint of human health and environmental quality to ensure that Dow products are not used in ways for which they are not intended or tested. Dow personnel are available to answer your questions and to provide reasonable technical support. Dow product literature, including safety data sheets, should be consulted prior to use of Dow products. Current safety data sheets are available from Dow. Medical Applications Policy NOTICE REGARDING MEDICAL APPLICATION RESTRICTIONS: Dow will not knowingly sell or sample any product or service ( Product ) into any commercial or developmental application that is intended for: a. long-term or permanent contact with internal bodily fluids or tissues. Long-term is contact which exceeds 72 continuous hours; b. use in cardiac prosthetic devices regardless of the length of time involved ( cardiac prosthetic devices include, but are not limited to, pacemaker leads and devices, artificial hearts, heart valves, intra-aortic balloons and control systems, and ventricular bypass-assisted devices); c. use as a critical component in medical devices that support or sustain human life; or d. use specifically by pregnant women or in applications designed specifically to promote or interfere with human reproduction. Dow requests that customers considering use of Dow products in medical applications notify Dow so that appropriate assessments may be conducted. Dow does not endorse or claim suitability of its products for specific medical applications. It is the responsibility of the medical device or pharmaceutical manufacturer to determine that the Dow product is safe, lawful, and technically suitable for the intended use. DOW MAKES NO WARRANTIES, EXPRESS OR IMPLIED, CONCERNING THE SUITABILITY OF ANY DOW PRODUCT FOR USE IN MEDICAL APPLICATIONS. Disclaimer NOTICE: No freedom from infringement of any patent owned by Dow or others is to be inferred. Because use conditions and applicable laws may differ from one location to another and may change with time, the Customer is responsible for determining whether products and the information in this document are appropriate for the Customer s use and for ensuring that the Customer s workplace and disposal practices are in compliance with applicable laws and other governmental enactments. Dow assumes no obligation or liability for the information in this document. NO WARRANTIES ARE GIVEN; ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ARE EXPRESSLY EXCLUDED. For additional information, not covered by the content of this document, contact us via our web site Page 7 of 7 Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow Effective Date: 8/8/2014